首页 > 资讯 > FDA仿制药办公室五月仅批准20件ANDA

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2014-06-16 Lachman CONSULTANTS

五月仅有20件ANDA获批这一统计数字（数字来源于CDER的申请批准报告），无疑会让CEO们心痛不已，除非有更多的ANDA获批，不然业界可能要开始质疑GDUFA目标了。正如我之前写的，签发完全回应函（CRL）是基于GDUFA指标的成功举措，但收到CRL的产品并不能上市销售。如果没记错的话，单月批准20件也许是自上世纪80-90年代仿制药丑闻起，批准量最低的一次。

我还在FDA时候我们就常说，“把货运走”这一理念确实促使OGD职员尽力将申请批准并送出自己的办公室大门。在目标函里概述的GDUFA指标中，成功与否取决于CRL的签发而不是申请的批准。对于目标函的讨论已经有许多了，这也代表着在2017年10月1日GDUFA 2再协商修订之前，仿制药行业将必须在充斥着对目标函的讨论中生活（而且除了GDUFA我看不到任何仿制药行业可以将就的办法，除非国会再对仿制药计划追加3亿美元的拨款，但这似乎不大可能）。大家也理解OGD并不是对批准的问题坐视不理，他们也意识到了，在申请获批之前，会被一轮又一轮地审评。

随着OGD争先提供行业渴望的指南文件、培训数量可观的新职员、在GDUFA计划下制定新的政策，以前许多只配置给审评的资源现在逐步分散给了这些必要的环节中。但行业究竟会给OGD多少时间让它转变？需要有什么样的进展才足以让行业看到隧道口的光亮？这些都是好问题，就让我们一起来期待这道光亮不是对面驶来的列车灯光！

如果批准数还没有增加，业界会继续以CRL的签发来评判GDUFA的成就吗？还是会将底线放在施加必要的政治压力上？即使业界坐在了谈判桌上，在目标函的简单叙述和业界的要求之间会不会出现裂缝？只有时间可以说明一切，因为GDUFA指标将适用于2014年10月1日起提交的新申请，距离今天只剩下110天了。

Lachman CONSULTANTS - Bob Pollock先生 2014-06-12
校译：识林-柯 2014-06-16

OGD Approves Only 20 ANDAs in May
Written by Bob Pollock • June 12, 2014

With the approval of only 20 ANDAs in May (information derived from the CDER application approvals report), a statistic that is sure to give CEOs heartburn, the industry may start to question the GDUFA goals, unless many more ANDAs are driven to approval. As I have written before, Complete Response Letters (CRL) are the measure of GDUFA success based on the GDUFA metrics, but you can't market products that receive Complete Response Letters. If I am not mistaken, the 20 monthly approvals are perhaps the lowest since the generic drug scandal back in the late 1980s and early 1990s.

As we used to say when I was at the FDA, the concept of “moving the freight” really motivated OGD staff to getting approvals out the door. Under the GDUFA metrics as outlined in the Goals Letter (here), success is measured by issuance of CRLs and not by approvals. Much has been said about the Goals Letter and it represents the mantra that the industry must live by until GDUFA 2 is negotiated and revised prior to October 1, 2017 to extend the program (and I don’t see any way the industry could make do without the program unless Congress came up with $300 million of additional appropriated funding for the generic program, which is not likely). It is understood that the Office of Generic Drugs (OGD) is not turning a blind eye to the issue of approvals and they recognize that, until an application is approved, it will cycle back through the review process again and again.

With OGD racing to provide Guidance documents that industry is hungry for, with their involvement in training a significant number of new staff, and also developing policy under the GDUFA program, many of the resources that were previously devoted to nothing but application review have been diverted to accomplish these necessary tasks. But how long will Industry give OGD to turn the corner? What type of progress will need to be demonstrated before industry begins to see the light at the end of the tunnel? Good questions, and let’s hope the light is not that of another train coming down the tracks!

Will industry continue to judge success of GDUFA by CRLs or will their bottom line necessitate exerting political pressure if the number of approvals does not increase? Is there a disconnect between the plain reading of the Goals Letter and the industry, even though the industry was at the negotiating table? Only time will tell, as the GDUFA metrics begin for new applications submitted on or after October 1, 2014, which is only 110 days from today.

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